We help our clients make critical decisions with respect to their investments in the development of new medical products and address their greatest challenges, from selecting the right compounds to enter the clinic, to designing and executing highly efficient development programs and successfully navigating the regulatory process.

NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The company distinguishes itself from other consultancies through its ability to assign top-tier Expert Consultants on all engagements, its ability to provide the full spectrum of functional expertise needed to conduct complete product development programs from bench to marketing authorization, and its leadership in working with early-stage development companies. Services include development and regulatory strategy, expert scientific and technical advice, operational planning and oversight, contract development services including full program planning and management, and expert witness services for national and global law firms servicing the biopharmaceutical industry.

Contact us at info@NDApartners.com or call 540-738-2550 to discuss your requirements and learn more about how NDA Partners can help you design and execute a world-class product development program.

For more than a decade, NDA Partners® has provided high-value expert consulting services to assist its clients in addressing their most complex and demanding requirements for medical product development. Our clients are global pharmaceutical companies, emerging biopharmaceutical companies, medical device companies, law firms that serve the medical products industry, and private investment firms in the life sciences space. We help early-stage biopharma companies identify the most appropriate regulatory pathways, prepare efficient and effective product development plans, assess data, evaluate readiness for regulatory submissions, prepare for meetings with regulatory agencies, and prepare and submit regulatory applications. We help Asian and European pharmaceutical companies navigate US regulatory requirements and assist US companies in entering global markets. We provide litigation support and expert testimony for law firms dealing with complex issues of patent infringement, product liability, and supply chain failures. We assist investment funds with due diligence and in addressing difficult development, regulatory, and scientific issues faced by portfolio companies. Often, our clients are tomorrow’s industry leaders, and we help them design and execute development programs and bring their products to market.

The Partners and Expert Consultants affiliated with NDA Partners are some of the most well-known and well-respected industry, academic, and regulatory professionals in the world. They include three former US Food and Drug Administration (FDA) Center Directors; the former Head of the UK Medicines and Healthcare Products Regulatory Agency (MHRA); the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP), more than 30 former senior-level regulatory agency executives; dozens of former pharmaceutical industry senior executives; and a deep roster of highly proficient experts in specialized functional areas. The company’s Expert Consultants possess an unsurpassed knowledge of the product development and regulatory environment and are thoroughly familiar with the review expectations in various regulatory agency divisions. By utilizing the very best talent available anywhere in the world, NDA Partners delivers extraordinary value to its clients.

While most consulting firms in the biopharma industry focus on a specific functional area, NDA Partners has depth in all areas of product development, including regulatory strategy, nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control, quality management systems, compliance, clinical development, therapeutic area experts, regulatory submissions, and development program management. NDA Partners is unique in that it can assemble project teams to address virtually any issues arising over the course of a product development program, and design and manage full product development programs on behalf of its clients.

NDA Partners’ clients include many early-stage innovator companies and small-to-medium size biopharma and device companies with a limited portfolio of new products in development. Most of these companies are investor-funded and face the constant challenge of meeting milestones attached to the last round of funding and closing the next round. NDA Partners is experienced in working in this challenging and dynamic environment and plays a key role not only in assisting clients in meeting funding milestones, but also in enhancing their credibility with investors through the assignment of highly experienced Expert Consultant teams to advance their development programs in the most efficient manner, and with a high likelihood of regulatory success.